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Clinical Trials/NCT01952405
NCT01952405
Completed
Not Applicable

Efficacy of Dialectical Behavior Therapy in Patients With Borderline Personality Disorder: a Controlled Trial in Taiwan

Mackay Memorial Hospital1 site in 1 country60 target enrollmentMay 18, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Borderline Personality Disorder
Sponsor
Mackay Memorial Hospital
Enrollment
60
Locations
1
Primary Endpoint
Suicide Attempt Self-Injury Interview (SASII)
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The purpose of this study is to test the hypothesis:

Primary hypothesis: Participants in the dialectical behavior therapy group have greater reductions in the frequency and severity of suicidal and non-suicidal self-injurious behaviors compared to participants in the alternative treatment group.

Secondary Hypotheses: Participants in dialectical behavior therapy group have improved treatment outcomes compared to participants in alternative treatment, including mental health service utilization, symptoms of borderline personality and depression symptoms, suicidal thought and hopelessness, disability, and quality of life.

Detailed Description

This study will be a 3-year randomized control trial. Patients will be referred from any mental health services in Taipei area who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria for Borderline Personality Disorder. Inclusion criteria include subjects who fulfill the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria for Borderline Personality Disorder, 18-60 years of age, sign the informed consent, have had at least two episodes of suicidal or non-suicidal self-injurious episodes in the past 5 years, and at least one of which is in the 3 months preceding enrollment. The exclusion criteria include psychotic disorder, bipolar I disorder, severe physical illness, and mental retardation. Outcome measures will be obtained at pre-treatment, 4-month, 8-month and post-treatment (12-month) during 1-year protocol. Using semi-structured interview and a battery of self-report forms, a range of symptoms and behaviors associated with Borderline Personality Disorder will be assessed including suicidal thought, suicide attempt, depression, hopelessness, quality of life, disability, service utilization, and function. Measures are selected based on previous outcome studies of dialectical behavior therapy. Outcome variables will be evaluated by blinded assessors.

Registry
clinicaltrials.gov
Start Date
May 18, 2013
End Date
February 24, 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shen-Ing,Liu

Senior Visiting Staff

Mackay Memorial Hospital

Eligibility Criteria

Inclusion Criteria

  • meeting DSM-IV criteria for borderline personality disorder
  • 18-60 years of age
  • have had at least two episodes of suicidal or non-suicidal self-injurious episodes in the past 5 years,
  • at least one episode of suicidal is in the 3 months preceding enrollment
  • agreement to participate in evaluation of the program.

Exclusion Criteria

  • bipolar I disorder, delirium, dementia, mental retardation, or a diagnosis of substance dependence in the preceding 30 days
  • living outside of Taipei area
  • having any serious medical condition likely to require hospitalization within the next year (e.g. cancer)
  • and having plans to leave the Taipei area in the next 1 year

Outcomes

Primary Outcomes

Suicide Attempt Self-Injury Interview (SASII)

Time Frame: 4 months, 8 months and 12 months

change from baseline in Suicide Attempt Self-Injury Interview at 4 months, 8 months and 12 months

Secondary Outcomes

  • Beck Hopelessness Scale (BHS)(4 months, 8 months and 12months)
  • Borderline Personality Disorder Subscale(4 months, 8 months and 12 months)
  • Brief Disability Questionnaire (BDQ)(4 months, 8 months and 12 months)
  • Borderline Symptom Checklist (BSL-23)(4 months, 8 months and 12 months)
  • The Patient Health Questionnaire (PHQ-9)(4 months, 8 months and 12 months)
  • Symptom Checklist-90-Revised (SCL-90-R)(4 months , 8 months and 12 months)
  • Beck Scale for Suicide Ideation (BSSI)(4 months , 8months and 12 months)
  • Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q SF)(4 months, 8 months and 12 months)
  • Clinical Global Impressions-Severity (CGI-S) and Improvement (CGI-I)(4 months, 8 months and 12 months)
  • Treatment History Interview (THI)(4 months, 8 months and 12 months)

Study Sites (1)

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